Environmental Influence on Mental Illness Via Modifications of Genomes and Metabolomes in Adolescents With Autism

NCT ID: NCT06299618

Last Updated: 2024-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-30

Study Completion Date

2025-12-31

Brief Summary

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The aim of the study is to enrich the understanding of the physiological mechanisms that predispose autistic adolescents to mental illness. It will inform a possible pathway and biomarker handprint of mental illness severity and prognosis to formulate a neurobiologically informed personalization strategy that could be applied for selecting appropriate Evidence Based Intervention (EBI) for treating an adolescent formally diagnosed with Autism.

Detailed Description

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The goal of this observational study is:

1. to identify environmental factors which may significantly contribute to the already vulnerable mental health of autistic adolescents in the age group of 11 - 15 years in developing mental illness;
2. to perform quantitative modelling of the Epigenetic - Genetic/Metabolomic - Mental health (EGM) process chain for designing control strategies based on the subjects' personal, environmental, historical, and current state.

Conditions

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Autism Autism Spectrum Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Autistic Adolescents
* Must be able to interact verbally
* Parental consent and participants must be able and willing to give written informed assent and to comply with the requirements of the study protocol
* Must be willing to return for all study visits and wear the study device at home
* Must have access to and be able to operate a smartphone.

Exclusion Criteria

* Adolescents with severe motor impairments or schizophrenia
* Complex medical conditions, which would interfere with ability to take part in the study visits or outcomes.
* Intellectual disability, not capable to attend mainstream school
Minimum Eligible Age

11 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southampton

OTHER

Sponsor Role collaborator

Carol Davila University of Medicine and Pharmacy

OTHER

Sponsor Role collaborator

Microlink PC UK LTE

UNKNOWN

Sponsor Role collaborator

Engineering Ingegneria Informatica SpA

UNKNOWN

Sponsor Role collaborator

MEDEA SRL

UNKNOWN

Sponsor Role collaborator

ORTHOKEY ITALIA SRL

UNKNOWN

Sponsor Role collaborator

University College Cork

OTHER

Sponsor Role lead

Responsible Party

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Dr. Deirdre Murray

Professor Deirdre Murray

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deirdre Murray, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Cork, Cork, Ireland

Geraldine Boylan, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Cork, Cork, Ireland

Mihai Berteanu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Medicine and Pharmacy, Bucharest, Romania

Samuele Cortese, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southampton, Southampton, UK

Koushik Maharatna, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southampton, Southampton, UK

Locations

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University College Cork

Cork, , Ireland

Site Status

University of Medicine and Pharmacy Carol Davila Bucharest

Bucharest, , Romania

Site Status

University of Southampton

Southampton, , United Kingdom

Site Status

Countries

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Ireland Romania United Kingdom

Central Contacts

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Project Manager

Role: CONTACT

+353(0)21 4205082

Facility Contacts

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Deirdre Murray, PhD

Role: primary

Jean Conway, Masters

Role: backup

Samuele Cortese, MD

Role: primary

Koushik Maharatna, PhD

Role: backup

Other Identifiers

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ENIGMA-I

Identifier Type: -

Identifier Source: org_study_id

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